Kornimate/medical-research-clean huggingface dataset:
perioperative oral nutrition supplementation in malnourished surgical cancer patients

Conditions: Cancer of Breast; Cancer Colon

Summary: the aim of this study is to evaluate the effectiveness of perioperative oral nutrition supplementation (ons) on nutritional status in malnourished cancer patients undergoing elective surgery. the hypothesis is pre-operative ons feeding in malnourished surgical cancer patients is effective on improving nutritional status. an extended period of 3 months post-operative ons feeding is effective on improving nutritional status as compared to ons feeding post-operatively during hospital stay only. perioperative feeding is effective on improving secondary outcomes such as sleep quality, post-operative complications and length of hospital stay.

the main objective of this study is to evaluate the effectiveness of perioperative oral nutrition supplementation (ons) on nutritional status in malnourished cancer patients undergoing elective surgery. the specific objectives are: 1. to evaluate the baseline nutritional status of cancer patients undergoing elective surgery 2. to evaluate the effectiveness of pre-operative ons feeding on nutritional status in malnourished surgical cancer patients 3. to evaluate the effectiveness of an extended 3 months post-operative ons feeding after discharge versus ons feeding only post-operatively during hospital on nutritional status 4. to evaluate secondary outcomes of perioperative feeding such as sleep quality, post-operative complications and length of hospital stay study design: this is a randomised-controlled-open label-parallel group(s)-trial which will be conducted on malnourished cancer patients undergoing elective surgery. study duration: the participation duration for each participant is 4 months. the completion of the study will take around 30 months.

Eligibility criteria:
inclusion criteria: * male or female from all ethnicity * 25 to 65 years * bmi not less than 18.0 kg/m² * cancer patients who are confirmed with elective surgery whose co-morbidities are stabilized based on the asa physical status classification system asa class 1 and 2 * fulfil at least two characteristics of and/ aspen diagnosis of malnutrition these characteristics are insufficient energy intake, weight loss, loss of muscle mass, loss of subcutaneous fat, localized or generalized fluid accumulation and diminished functional status as measured by handgrip strength. exclusion criteria: * patients who require enteral or parenteral feeding * pregnant or lactating * on chemotherapy or radiotherapy * total gastrectomy or ileostomy * metastasized cancer, upper gastrointestinal cancer, terminal diseases, decompensated liver or renal disease, major concurrent metabolic problem such as uncontrolled diabetes, dementia * on regular steroids prescription
evaluation of a full-face mask for the treatment of obstructive sleep apnea (osa)

Conditions: Obstructive Sleep Apnea

Summary: the investigation is designed to evaluate the comfort, ease of use and performance of a trial nasal mask for the treatment of obstructive sleep apnea (osa) in the home environment.

the investigation is a prospective, non-randomized, non-blinded study. up to 45 osa participants who currently use a full-face mask will be recruited. the study will involve a baseline (visit 1) data gathering with the participant's pap therapy and their usual mask. this will be followed by the participants being fitted with the trial full-face mask by a sleep technician for use in-home (visit 2). the participant then will come in to return the mask (visit 3) and give feedback on their experience using the mask in home in the form of a structured interview during visit 3. if the participants prefer the trial full-face mask they will be asked if they would like to continue using the trial mask for a further six months in home. there will be a follow up phone call gain feedback or address any issues at months 2 and 4 of the six month extension period. at the end of the six month extension period, the participants will return the trial full-face mask to ntlsc and answer a few questions around their feedback on the mask after using it for six months. the mask and cpap (if used from the loan research pool) will be returned to the institution at the conclusion of the trial and participant will return to their usual mask and therapy device for the treatment of obstructive sleep apnea. neither the investigators nor the participants will be blinded to the study. data from initial 2 week trial is reported here.

Eligibility criteria:
inclusion criteria: * ahi ≥ 5 from diagnostic psg night * aged 22 and over (fda defined as adult) * either prescribed apap, cpap or bi-level pap for osa * existing full-face mask users * fluent in spoken and written english exclusion criteria: * inability to give informed consent * patient intolerant to cpap therapy * anatomical or physiological conditions making pap therapy inappropriate * current diagnosis of respiratory disease or co2 retention * pregnant or think they may be pregnant.
split-course hypofractionated radiotherapy with concurrent chemotherapy in locally advanced non-small cell lung cancer

Conditions: Non-small Cell Lung Cancer

Summary: this phase ii study is to determine the efficacy of split-course thoracic radiotherapy plus concurrent chemotherapy with or without consolidation immunotherapy for patients with local advanced non-small cell lung cancer.

this phase ii study is to determine the efficacy of split-course thoracic radiotherapy plus concurrent chemotherapy with or without consolidation immunotherapy for local advanced non-small cell lung cancer patients. patients were treated with hypo-rt (30gy in 6 fractions) followed by hypo-boost (30gy in 6 fractions) combined with concurrent weekly chemotherapy (docetaxel 25 mg/m2 and cisplatin 25 mg/m2). consolidation immunotherapy were recommended for those without disease progression or persistent grade2+ toxicities following radiotherapy. the primary end point is progression-free survival, which is the time that passes from the first day of radiotherapy to the date at which disease progresses. progression-free survival will be calculated using the kaplan-meier method.toxicities will be graded according to ctcae v. 5.0.

Eligibility criteria:
inclusion criteria: * histologically confirmed non-small cell lung cancer (nsclc) by bronchoscopy, ct-guided biopsy, and endobronchial ultrasonography * unresectable stage iii disease based on the seventh edition of the tnm (tumor, node, metastases) staging system proposed by the american joint committee on cancer * measurable lesions according to the response evaluation criteria in solid tumors (recist) criteria * eastern cooperative oncology group (ecog) performance status score of 0 to 1; * charlson comorbidity index score ≤4 * previously treated with chemotherapy or treatment-naive * no previous chest radiotherapy, immunotherapy or biotherapy * hemoglobin≥10 mg/dl, platelet≥100000/μl,absolute neutrophil count ≥1500/μl * serum creatinine ≤1.25 times the upper normal limit(unl), or creatinine clearance≥60 ml/min * bilirubin ≤1.5 times unl, ast（sgot）≤2.5 times unl ,alt（sgpt）≤2.5 times unl,alkaline phosphatase ≤5 times unl * cb6 within normal limits * patients and their family signed the informed consents exclusion criteria: * previous or recent another malignancy, except nonmelanoma skin cancer or cervical cancer in situ * contraindication for chemotherapy * malignant pleural or pericardial effusion. * women in pregnancy, lactation period, or no pregnancy test 14 days before the first dose * women who has the probability of pregnancy without contraception * tendency of hemorrhage * in other clinical trials within 30 days * addicted in drugs or alcohol, aids patients * uncontrollable seizure or psychotic patients without self-control ability * severe allergy or idiosyncrasy * not suitable for this study judged by researchers

Keywords: non-small cell lung cancer split-course radiotherapy consolidation immunotherapy
post-marketing surveillance (special use-results surveillance) on long-term use with ryzodeg®

Conditions: Diabetes

Summary: this trial is conducted in asia. the aim of this non-interventional study is to investigate the long-term safety and effectiveness of ryzodeg® (insulin degludec/insulin aspart) in japanese patients with diabetes mellitus requiring insulin therapy under normal clinical practice conditions.


Eligibility criteria:
inclusion criteria: * signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol) * the decision to initiate treatment with commercially available ryzodeg® has been made by the patient/legally acceptable representative (lar) and the treating physician before and independently from the decision to include the patient in this study * patients with diabetes mellitus requiring insulin therapy for whom the physician has decided to start treatment with ryzodeg® * male or female, no age limitation exclusion criteria: * patients who are or have previously been treated with ryzodeg® * previous participation in this study. participation is defined as having given informed consent in this study * patients with a history of hypersensitivity to study product components * mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
a surgical simulation study to evaluate the safety of a device mechanism as treatment for vaginal apical prolapse

Conditions: Pelvic Organ Prolapse

Summary: the purpose of this pilot study is to perform a procedure to evaluate the safety of the placement of a new device (known as the vfix device).

in this study, the surgeon will not use the actual v-fix device. instead, the surgeon will use a routine operating room instrument, which is similar to the size and shape of the v-fix device to mimic the placement of the vfix device by using the routine operating room instrument to push the top of your vagina towards the ligament.

Eligibility criteria:
inclusion criteria: * age greater than or equal to 18 years. * subjects with apical support prolapse in whom the surgeon may consider a surgical procedure to correct level 1 support, with "c" or "d" descent at least halfway down the vaginal length (i.e. uterus and cervix or the vaginal vault in hysterectomised subjects), and having laparoscopy or abdominal surgery (additional surgery e.g. tubal ligation or ovarian cystectomy is also allowed). * vaginal examination during the screening visit confirms that the lateral fornix of the vagina can reach both the left and right ssl and therefore the surgical simulation can be performed. * the investigator considers that the subject is medically fit enough to receive extended anaesthesia of approximately 15 minutes, to complete the additional anatomical observation study procedures. * subjects agree to participate in the study and document this agreement by signing the ethics committee approved informed consent. exclusion criteria: * none
polarstem cementless hip stem

Conditions: Osteoarthritis

Summary: multicenter observational study to validate that the polarstem™ is a state-of-the-art implant in terms of radiographic, clinical performance and long-term survivorship.

the goal of this multicenter clinical observation is to validate short-, mid-, and long-term outcome (efficacy and safety) of the polarstem™. efficacy evaluations: * evaluation of function, range of motion (rom) and pain as assessed by harris hip score, hip disability and osteoarthritis outcome score (hoos) \[7, 8\], an extension of the western ontario and mcmaster universities osteoarthritis index (womac). * radiographic changes as defined by radiolucent lines, osteolysis, hypo- and hypertrophy, implant loosening or migration safety evaluations: * intra- and perioperative device-related adverse events (ae) and complications up to discharge * postoperative ae up to 10 years

Eligibility criteria:
inclusion criteria: * patient has no general medical contraindication to surgery * informed consent to participate in the mco signed by the patient * routine radiographic assessment is possible * patient is likely to comply with study follow-up requirements * primary total hip replacement (thr) to the affected side, unilateral or bilateral exclusion criteria: * previously failed endoprosthesis and /or thr components in relevant hip * history of infection in the affected joint; systemic infections * grossly insufficient femoral or acetabular bone stock in the involved hip * charcot joint disease or other severe neurosensory deficit * severe spinal disorders * age of patient at date of surgery \> 75 years * high comorbidity * cemented acetabular cup
gore-bioa fistula plug to treat transsphincteric fistulas

Conditions: Anal Fistula; Fecal Incontinence; Surgery

Summary: this is a prospective clinical study on the efficacy of gore-bioa fistula plug in high transsphincteric fistulas. follow-up time is six months

inclusion criteria for the study is a patient with ultrasound or mri proven high transsphincteric perianal fistula. patients with crohns disease, immunosuppressive medication, anovaginal fistula, radiation therapy or chemotherapy are excluded. a seton is placed in the fistula track for two months before the application of the plug. patients are followed up for six months. symptoms of fecal incontinence before and after intervention are monitored with the cleveland clinic incontinence score.

Eligibility criteria:
inclusion criteria: * age 18-70 years, male or female * high cryptoglandular perianal fistula * written approval for the study * sufficient co-operation for the study * localization of the fistula by ultrasound or mri exclusion criteria: * crohns disease * immunosuppressive treatment * anovaginal fistula * radiation therapy 6 months before study * chemotherapy 6 months before study * low- or intersphincteric fistula
migraine in electrohypersensitive patients

Conditions: Headache; Migraine

Summary: the investigators propose here by the use of the french version of the migraine disease screening questionnaire (id migraine ™) to study the prevalence of migraine disease in a population of electrohypersensitive patients


Eligibility criteria:
inclusion criteria: * informed consent * 18 years or older at the time of informed consent with all these criteria : * the perception by the subjects of various non-specific functional symptoms * the absence of clinical and biological evidence to explain the symptoms * the attribution by the subjects themselves of these symptoms to exposure to electromagnetic fields, which are themselves diverse * the symptoms are chronic (more than 3 months) * the symptoms appear during an exposure to a source of electromagnetic radiation and cease after the exposure is stopped * the symptoms are reproducible exclusion criteria: - age under 18 years old

Keywords: electrohypersensitivity
prospective, rct of split thickness skin grafts on lower leg after compression therapy with compression bandage vs. npwt

Conditions: Skin Cancer

Summary: the single center, prospective, randomized trial includes in total 60 patients. we want to compare two different treatment methods for compression therapy for split thickness skin graft in lower leg. the patients are randomized to compression therapy with npwt (negative pressure wound therapy) using the device pico or using the compression bandage with coban 2 lite. primary outcome is complete healing of the skin transplant 30 days postoperatively. secondary outcomes will be to note frequency of infection, bleeding, loss of transplant etc.


Eligibility criteria:
inclusion criteria: * \>18 years * signed informed consent * surgical wound (excision of skin cancer) exclusion criteria: * malignant melanoma * signs of infection * exposed tendon/bone in wound * burn/chronic wound

Keywords: split thickness skin graft lower leg compression therapy pico coban 2 lite
intervening early with neglected children

Conditions: Conduct Disorder; ADHD; Depression

Summary: this study will assess early and middle childhood outcomes of an intervention for neglecting parents that was implemented in the children's infancy. we expect that parents who received the attachment and biobehavioral catch-up intervention in infancy will be more nurturing and will follow children's lead more than parents who received a control intervention, and that children will show better outcomes in attachment, inhibitory control, emotion regulation, and peer relations than children of parents who received the control intervention.

children were randomly assigned to receive the abc intervention or a control intervention (def) in infancy. these two groups, plus a group of low-risk children, will be studied in early and middle childhood. of interest will be differences in parent and child outcomes that result from the intervention. hypothesis 1: neglected children whose parents received the abc intervention and low-risk comparison children will show better inhibitory control than neglected children whose parents received the def intervention. hypothesis 2: children in the abc intervention condition and low-risk comparison children will show better emotion regulation than children in the def condition. hypothesis 3: children in the abc intervention condition and comparison children will show less reactive aggression and less hostile attributional bias than children in the def condition. hypothesis 4: children in the abc condition and comparison children will show more normative cortisol production than children in the def condition. although we expect that sustained changes in parenting are critical for sustained changes in child behaviors, several alternative models will be tested. first, it is possible that when parents change as a result of the intervention in a child's infancy, there are positive outcomes for children regardless of whether the changes in parenting are sustained. if this is the case, early parenting will mediate the effects of the intervention when controlling for later parenting. second, if concurrent parenting is what is critical to child functioning, current parenting will mediate intervention effects on child outcomes when controlling for early parenting. third, longitudinal modeling of both parent and child behaviors allows for analysis of cross-lagged associations using structural equation modeling. such modeling can examine concurrent and transactional associations between parent and child. we can also examine associations between change at behavioral and biological levels. longitudinal modeling will be used to examine models of change in parenting behaviors and how those influence child outcomes.

Eligibility criteria:
inclusion criteria: * must have been in earlier randomized clinical trial exclusion criteria: -

Keywords: parenting parent child relations middle childhood outcomes
study on the registration of coronary heart disease patients undergoing pci

Conditions: Coronary Heart Disease

Summary: study on the registration of coronary heart disease patients undergoing pci in chinese's population. get the incidence of adverse events in these patients after pci, a clear type of adverse reaction, forms, influencing factors, to establish risk management processes, clinical safety and reasonable treatment, and provide the basis for further research and reference.

dual antiplatelet therapy, comprising a low-dose aspirin and a kind of p2y12 receptor inhibitors, has been the mainstay of the management in patients with acute coronary syndromes and/or undergoing percutaneous coronary intervention (pci). while variability to p2y12 receptor inhibitors is common in patients and is a major cause of adverse cardiovascular events. low response to p2y12 receptor inhibitors will result high platelet reactivity (hpr) and patients who exhibit hpr are at increased risk of atherothrombotic occlusion events. vice versa, high response to p2y12 receptor inhibitors will lead to low platelet reactivity (lpr) and increase the risk of hemorrhage.now, the absence of a universal definition of therapeutic window for different racial and actual clinical situations and lacking the gold standard test to quantify it limit the use in clinic practice.so this clinical trial try to use patient's platelet reactivity combine with type of adverse reaction, forms, influencing factors to find a proper therapeutic windows for p2y12 receptor inhibitors in chinese people.

Eligibility criteria:
inclusion criteria: * chinese's patients diagnosed with coronary heart disease and accept stent implantation. * accept aspirin and p2y12 receptor inhibitors (clopidogrel or ticagrelorwere）after stent implantation. * willingness and ability to sign informed consent. * can communicate effectively and complete the trial. exclusion criteria: * occurrence of a major complication during the procedure of percutaneous coronary intervention or before platelet function testing. * allergy or intolerance to aspirin or p2y12 receptor inhibitors (clopidogrel or ticagrelor）

Keywords: coronary heart disease pci anti-platelet agents
musculoskeletal non-tumoral pathology quantitative perfusion

Conditions: Osteonecrosis; Pseudarthrosis; Compartment Syndrome

Summary: study on quantitative perfusion parameters acquired on mr imaging of patients with non-tumoral pathology of the musculoskeletal system.

patients referred for the mr imaging evaluation of non-tumoral musculoskeletal pathology (osteonecrosis, pseudarthrosis and compartment syndrome) will have their mr protocols complemented by a contrast enhanced perfusion study. in this patients standard clinical evaluation is already performed with contrast medium injection (gadolinium) and no additional injection is required. after post processing multiple quantitative perfusions parameters will be extracted (e.g. plasmatic volume, transfer constant, backflow constant, extra-cellular extra vascular space volume). the variation of these parameters in patients with and without the previously described conditions will be compared.

Eligibility criteria:
inclusion criteria: * affiliation to a social security regimen * signature of an informed consent * clinical suspicion of one of the studied conditions (osteonecrosis of the wrist, osteonecrosis of the femoral head, pseudarthrosis and compartment syndrome) exclusion criteria: * mr contraindications * contraindications to contrast injection * previous history of allergy to gadolinium containing contrast medium * presence of metallic hardware in the study zone * pregnancy * patients under tutelage

Keywords: magnetic resonance imaging perfusion quantitative
intravitreal adalimumab in patients with choroidal neovascularization secondary to age-related macular degeneration

Conditions: Age-Related Macular Degeneration; Choroidal Neovascularization

Summary: adalimumab is a humanized recombinant monoclonal antibody fragment targeted against tumor necrosis factor. this study will assess the safety and efficacy of intravitreal adalimumab administered in patients with choroidal neovascularization secondary to age-related macular degeneration non-responders to the conventional treatment with intravitreal ranibizumab.


Eligibility criteria:
inclusion criteria: - choroidal neovascularization secondary to age-related macular degeneration non-responders to the conventional treatment with ranibizumab (active choroidal neovascularization after loading phase of one injection per month for three consecutive months, followed by a maintenance phase with 5 injections in the last 12 months or 3 injections in the last 6 months exclusion criteria: * only one functional eye * hypersensitivity to adalimumab or any component of the formulation * previous systemic treatment with adalimumab * cancer * life expectancy \<1 year